Senior Specialist, Regulatory Management

Description

What Regulatory Mgmt contributes Responsible for development and deployment of policies and programs to minimize risk and enable compliant business operations
What is expected of you for success in your role
Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk
Supports the development of programs, policies and procedures using knowledge of regulatory requirements and technologies
Assesses and supports the management of risk
What is expected of you and others at this level in Quality & Regulatory Affairs for functional success
Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces
Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.
Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.
Encourages informed Risktaking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity
Accountabilities in this role
Manage Medical Distribution Facility Licensing required to distribute drugs and devices
Ensure compliance with State and Federal Laws and regulations
Identify and Quantify Risk
Work with the Cardinal Health Legal department and Sate Government Boards to remain current on state and local rules and regulations for the distribut ion of drugs and devices. Manage the policy governing licensing requirements
Manage 3PL Licensing required to distribute drugs and devices
Ensure compliance with State and Federal Laws and regulations
Work with the 3PL partner t o obtain sourcing and ensure compliance in each facility
Support and maintenance the 3PL complaint policies and forms
Manage 3PL Complaints
Be the point of contact (POC) for the 3PL customer
Work with the CAH distribution facilities to insu re the complaint is investigated in compliance with Cardinal Health Policy
Participate, as necessary in current IT project workshops, Kaizan and Black Belt events (MBT, License Tracker Management/Development, etc.) as a SME relating to Facility Licensing, 3PL Complaints, etc.
Provide support for field personnel relating to Licensing, 3PL Complaints, VAWD accreditation, License Tracker navigation, etc.
Identify quality and reg ulatory areas of improvement within current processes, investigate and provide recommendations.
Interact with crossfunctional business partners (Customers, Field Operations/Quality, Legal, Tax, Finance, Real Estate, Inventory, Sourcing, State Boards of Pharmacy, etc.) to assist in execution of the current Medical Distribution Quality Plan.
Qualifications
Bachelor's degree preferred
24 years experience FDA regulations for prescription drugs and medical devices (21 CFR) preferred
Knowledge of state regulations/requirements for the purchase, sale and distribution of drugs and medical devices (21 CFR) preferred
Distribution Operations processes (Medical and Pharmaceutical) preferred
Excellent verbal, written , computer, SAP, and interpersonal skills required
Positive Attitude
Fast, Efficient, Accurate and Hard Working
Detail Oriented
Project focused